a. Field of the Invention
This disclosure relates to a system, method of manufacturing, and method for determining the likelihood of barotrauma occurring in tissue during an ablation procedure performed on the tissue. More particularly, the instant disclosure relates to a system and method for determining the likelihood of endocardial barotrauma occurring in cardiac tissue during the formation of a lesion therein as a result of an ablation procedure being performed thereon
b. Background Art
During ablation procedures, such as, for example, cardiac ablation procedures, adverse events may occur resulting in damage to the tissue being ablated (e.g., charring of the tissue and localized coagulation) that, in turn, may result in even worse consequences such as stroke or death. In RF ablation, one such adverse event, though rare, is the occurrence of endocardial barotrauma, or “steam pops.” Endocardial barotrauma may occur, for example, when water in the blood and/or tissue boils as a result of the RF energy applied to the tissue. Accordingly, it is desirable to be able to predict or determine when events, such as endocardial barotrauma, are going to occur before they occur in order to take preventive measures. Unfortunately, in conventional or current systems the risk or likelihood of endocardial barotrauma occurring is not consistently evaluated or determined.
One conventional means for assessing the risk or likelihood of endocardial barotrauma occurrence is to monitor tissue temperature during an ablation procedure. Endocardial barotrauma occurs due to heating of the cardiac tissue above 100° C. during application of RF energy or power, however, no accurate means exists to measure tissue temperature. Some conventional systems may contain a thermistor, thermocouple, or some other temperature sensor in the tip of the ablation catheter, however, factors, such as blood flow or saline irrigation, for example, significantly affect the tip temperature, thereby making these temperature values difficult to interpret.
Other convention means by which endocardial barotrauma occurrence is prevented, or at least the risk of occurrence is managed, include monitoring the impedance drop during the RF delivery, and/or limiting the RF power being delivered to the tissue. These means or methodologies have proved to be less than optimal in the prediction or determination of the likelihood of endocardial barotrauma occurring in the tissue.
Accordingly, the inventors herein have recognized a need for a system and method for determining the likelihood of endocardial barotrauma occurring in tissue during the formation of a lesion therein as a result of an ablation procedure being performed thereon that will minimize and/or eliminate one or more of the deficiencies in conventional ablation systems.